Kornimate/medical-research-clean huggingface dataset:
a proof of concept study to evaluate the effectiveness of ustekinumab in hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

an open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa. twenty patients will be included. they will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28. patients will be followed up untill week 40.

Eligibility criteria:
inclusion criteria: * 18 years or older * hidradenitis suppurativa hurley stage ii or iii * no response to conventional local and oral antibiotics, or immunnesuppressive medication, or tnf-alpha inhibitors or surgery * the patient has to be able to complete a dutch questionnaire * informed consent must be obtained exclusion criteria: * not able to complete a dutch questionnaire * pregnancy or breast feeding * active hepatitis b or c infection, hiv or tuberculosis * treatment with biologics or other immunosuppressive medicine in the previous 3 months * malignancies in the last 10 years with the exception of basal cell carcinoma * demyelinating disorders * heart failure * known allergy to ustekinumab or to its preservatives * live vaccins in the next 3 months sever liver or renal failure

Keywords: hidradenitis suppurativa acne ectopica inverse acne ustekinumab stelara
phase 1 intravenous citrulline for the prevention of bronchopulmonary dysplasia in preterm infants

Conditions: Bronchopulmonary Dysplasia

Summary: premature infants are at risk for developing bronchopulmonary dysplasia (bpd). l-citrulline may decrease that risk, but we do not know the safety or dose of this drug for use in premature babies. the purpose of this study is to determine the safety and optimal dose of intravenous l-citrulline in premature infants.

this is a prospective phase i study of the safety, pharmacokinetics, and optimal dose of intravenously administered l-citrulline in premature infants born at 24 to 29 weeks estimated gestational age (ega) and who are at risk for bronchopulmonary dysplasia (bpd). this is a classic dose escalation using initial doses of 10 mg/kg of intravenous citrulline and advancing the dose by 10 mg/kg every 3 patients for a target peak plasma citrulline concentration of 100 umol/l. these infants will undergo intense hemodynamic monitoring and have intermittent blood sampling to determine levels of amino acids and nitric oxide metabolites. from this, we will determine citrulline pharmacokinetics including half life, clearance, and volume of distribution. intravenous l-citrulline will be provided by asklepion pharmaceuticals and mixed by the investigational drug service of the vanderbilt hospital clinical pharmacy. the study will be monitored closely by a data safety monitoring board (dsmb) consisting of clinicians not involved with this study.

Eligibility criteria:
inclusion criteria: * 24-29 weeks gestation * respiratory distress requiring intubation and mechanical ventilation or positive pressure oxygen at 24 hours of life * parents willing and able to sign consent exclusion criteria: * congenital malformation * suspected genetic or metabolic syndrome * surgical condition * life expectancy \< 24 hours * pre-existing, sustained hypotension * birth weight \< 500 grams * any condition which, in the opinion of the investigator, will interfere with the study objectives.

Keywords: bronchopulmonary dysplasia prematurity lung disease preterm infants
cerebellar alterations in individuals with a cannabis use disorder

Conditions: Cannabis

Summary: the purpose of this study is to investigate if individuals with a cannabis use disorder have an impaired cerebellar function by assessing possible alterations to their implicit adaptation during a visuomotor rotation task.


Eligibility criteria:
inclusion criteria: * patients diagnosed with a cannabis use disorder following diagnostic and statistical manual (dsm-v) criteria. * patients screen positive to cannabis in the urine analysis performed a week prior to assessment. * right-handed patients. * patients provide a signed consent. exclusion criteria: * patients with another current substance use disorder (with the exception of tobacco). * patients with a visual impairment that has not been corrected. * patients with a cognitive impairment such as mental retardation. * patients with psychotic disorders.

Keywords: learning cerebellum
vision improvement for legally blind dry amd patients

Conditions: Dry Age-related Macular Degeneration; Vision Impairment and Blindness

Summary: this retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry amd patients.

this retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry age-related macular degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.

Eligibility criteria:
iinclusion criteria: * male or female * any race * patient is at least 50 years old. * patient must have dry amd in the study eye. * patient is legally blind due to amd - i.e., has corrected distance visual acuity (cdva) of 20/125 or worse (45 letters; logmar ≥ 0.80) in the study eye. * patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires). * patient is not a contact lens wearer. * patient is willing and able to comply with all examinations. * patient must be competent to sign an informed consent form before study entry. exclusion criteria: * visually significant cataract in the study eye * presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye * any visually significant disease process in any ocular structure other than amd that would affect vision in the study eye * previous corneal surgery in the study eye * presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or may confound the outcome of the study

Keywords: amd, vision impairment, blindness
tislelizumab combined with chemotherapy (capox) in the perioperative treatment of msi-h/dmmr stage ii or iii colorectal cancer

Conditions: MSI-H Colorectal Cancer; Tislelizumab; Oxaliplatin; Capecitabine

Summary: this study is a multi-center, single-arm, open-label phase ii clinical trial, aiming to observe and evaluate the perioperative treatment of tislelizumab combined with chemotherapy (capox) in stage ii or iii colorectal cancer with msi-h/dmmr patient efficacy and safety.


Eligibility criteria:
inclusion criteria: 1. ecog: 0\~1; 2. patients with colon or rectal adenocarcinoma confirmed by histology or cytology; 3. the tissue specimens are confirmed as msi-h by pcr or ngs. if the patients are dmmr by immunohistochemistry, they need to be confirmed as msi-h by pcr (2021 expert consensus on immunotherapy for patients with colorectal cancer); 4. patients with clinical stage ii or iii (ct3-t4 n0 m0 or tany n+m0, clinically positive lymph nodes are defined as any lymph node ≥ 1.0 cm); 5. expected survival period ≥ 12 weeks; 6. the subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits. exclusion criteria: 1. have received anti-tumor therapy; 2. have received pd-(l)1 or ctla-4 treatment; 3. the patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma that has been completely remitted in childhood and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included); 4. patients are using immunosuppressants or systemic hormone therapy to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other equivalent hormones), and continue to use within 2 weeks before enrollment; 5. patients with any severe and/or uncontrolled diseases 6. urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity \> 1.0g; 7. pregnant or lactating women; 8. patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 9. those who have a history of psychotropic drug abuse and cannot quit or patients with mental disorders;
advate post authorization safety surveillance

Conditions: Hemophilia A

Summary: the primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to advate use, in subjects receiving advate in routine clinical practice.


Eligibility criteria:
inclusion criteria: * subject has moderate or severe hemophilia a (baseline fviii less than or equal to 5%) * subject currently has no measurable fviii inhibitor titer greater than or equal to 1 bu (bethesda or nijmegen method) * subject has been prescribed advate by their treating physician * subject may be of any age * subject or parent/legally authorized representative has provided written informed consent exclusion criteria: * none
patient-initiated episodic treatment of recurrent genital herpes in black patients

Conditions: Genital Herpes

Summary: this study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in black patients with recurrent genital herpes


Eligibility criteria:
inclusion criteria: * black men or women 18 years or older * history of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy * documented herpes simplex virus type 2 (hsv-2) seropositivity * willingness to discontinue suppressive therapy during study, if applicable * willingness and ability to comply with the study protocol exclusion criteria: * pregnant or breastfeeding women * women of childbearing potential not using accepted methods of contraception * hypersensitivity to famciclovir or drugs with similar chemical structures * renal dysfunction * known or suspected to have decompensated liver disease * known to have gastrointestinal malabsorption * known to be immunocompromised * known to be hypersensitive to ingredients in study medication * other protocol-defined inclusion/exclusion criteria may apply

Keywords: recurrent genital herpes black population
ticagrelor versus clopidogrel in left ventricular remodeling after st-segment elevation myocardial infarction

Conditions: ST Elevation Myocardial Infarction

Summary: the purpose of the study is to evaluate the novel role of ticagrelor to improve long-term lv remodeling following st-segment elevation myocardial infarction.

the investigators designed the healing-ami study to compare the influence of ticagrelor (180 mg loading and 90 mg twice daily maintenance) vs. clopidogrel (600 mg loading and 75 mg daily maintenance) on long-term left ventricular (lv) remodeling measured by 3d echocardiography in stemi patients undergoing primary pci. the primary objective of the healing-ami study is to demonstrate the novel role of long-term ticagrelor therapy in reducing the risk of lv remodeling,. the secondary objectives are to reveal the cross-talk between platelet and inflammatory process in st-segment elevation myocardial infarction (stemi) patients. moreover, this study will determine whether the high platelet inhibition by ticagrelor culminate the protection of infarcted myocardium.

Eligibility criteria:
inclusion criteria: * 18 years and older. * first-time onset stemi patients uneventfully treated with primary pci within 12 hours of onset of symptom. * infarct-related artery with timi 0, 1, or 2 grade flow at the time of initial diagnostic angiography (before wire passage). * proximal or mid-portion lesion of epicardial coronary artery. exclusion criteria: * previous history of myocardial infarction. * left bundle branch block on ecg at the time of screening. * cardiogenic shock at the time of randomization. * refractory ventricular arrhythmias or atrial fibrillation. * new york heart association class iv congestive heart failure. * severe or malignant hypertension (sbp\> 180 and/or dbp\> 120 mmhg). * fibrinolytic therapy. * history of hemorrhagic stroke. * intracranial neoplasm, arteriovenous malformation, or aneurysm. * ischemic stroke within 3 months prior to screening. * platelet count \< 100,000/mm3 or hemoglobin \< 10 g/dl. * a need for oral anticoagulation therapy that cannot be safely discontinued for the duration of the study. * women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding. * unable to cooperate with protocol requirements and follow-up procedures. * a history of p2y12 receptor inhibitor pretreatment (at least prior 1 month). * an increased risk of bradycardia. * concomitant therapy with a strong cytochrome p-450 3a inhibitor or inducer.

Keywords: st elevation myocardial infarction. ticagrelor left ventricular remodeling platelet reactivity
nocturnal hypertension and nocturia in african american men

Conditions: Hypertension

Summary: this study to obtain pilot data on nocturnal hypertension and nocturia. in dr. victor's current nih grant (cut your pressure too: the la barbershop blood pressure study) the results show that uncontrolled systolic hypertension is independent determinantal of nocturia in african american men. we now went to pursue this correlation by designing a new nih grant proposal to determine whether replacing short acting with long acting drugs and dosing them at bed time rather than in the morning will: a. lower the systolic blood pressure during sleep b. improve nocturia and results in better sleep quality. the results suggest that short acting hydrochlorothiazide may contribute to nocturia in some patients.

aims and significance of pilot data determine: 1. the feasibility of southern california registry as an effective measure to recruit african american men to participate in a new research program. 2. if men will comply with the study procedures including actigraphy and ambulatory blood pressure monitors. 3. the within subject coefficient of variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure monitoring, vertical activity at night by actigraphy monitors. 4. whether the ambulatory blood pressure itself affects the sleep pattern on actigraphy. 5. nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with self-reported nocturia ≥2 at night than in men with no reported nocturia. purpose: obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.

Eligibility criteria:
inclusion criteria: * african american men * age 35 to 79 year-old * able to give informed consent * pass the home sleep study * willing to wear the wrist actigraphy monitor for 9 days continuously. * willing to wear ambulatory blood pressure monitoring (abpm) for 48 hours twice during the 9 days of the study period. exclusion criteria: * diabetes mellitus * taking prostate medication * symptoms of prostate disease or urinary urgency * sleep apnea 1. a neck circumference greater than 17 inches 2. using continuous positive airway pressure (cpap) 3. history of a diagnosis of sleep apnea 4. apnea hypopnea index (ahi) \> 15 per hour
evaluating the efficacy of i-fiber pearl on reducing body fat accumulation in obese subjects

Conditions: Overweight and Obesity

Summary: the aim of this study is to investigate the effects of i-fiber pearl on body weight and body fat in obese adults.

this randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) i-fiber pearl, n=25. during the 12 weeks intervention, the subjects should take 200g placebo or 200g i-fiber pearl a day . the two pearl are supplied in plastic packages, and both the products taste the same. subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.

Eligibility criteria:
inclusion criteria: * female * aged 20-50 years old * body mass index is greater than or equal to 27 kg/m2 * waist greater than or equal to 80 cm exclusion criteria: * subjects diagnosed with cancer and on curative care. * subjects diagnosed with heart disease and on curative care. * subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug. * subjects with systemic infection requiring antibiotics.
rituximab versus observation as maintenance therapy in chronic lymphocytic leukemia (chronic lymphocytic leukemia)

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of the study is to evaluate the ability of rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a rituximab induction therapy.


Eligibility criteria:
inclusion criteria: * b-cll * age \>18 * ecog performance status 0-2 * previous rituximab containing induction treatment of the cll in 1st or 2nd line * patient must be in complete remission or partial remission after an induction treatment containing rituximab * anc (absolute neutrophil count) \> 1,0 x 10e9 /l * life expectancy \> 6 months * patient´s written informed consent * patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter exclusion criteria: * active uncontrolled bacterial, viral or fungal infection * significantly reduced organ functions and bone marrow dysfunction not due to cll * creatinine clearance of below 30ml/min * patients with a history of other malignancies within 2 years prior to study entry * patients with a history of severe cardiac disease * other known comorbidity with the potential to dominate survival * transformation to aggressive b-cell malignancy * hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs * medical condition requiring prolonged (\> 1 month) use of oral corticosteroids * pregnant or breast feeding women * any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Keywords: cll rituximab maintenance
comparison of nn1250 with insulin glargine in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe and in the united states of america (usa). the aim of this trial is to investigate the efficacy and safety of nn1250 (insulin degludec) in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies * current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, nph insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy * hba1c maximum 10.0 % by central laboratory analysis * body mass index (bmi) below or equal to 35.0 kg/m\^2 * ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening * ability and willingness to adhere to the protocol including performance of self measured plasma glucose (smpg) profiles and self adjustment of insulin doses exclusion criteria: * use within the last 3 months prior to visit 1 of any antidiabetic glucose lowering drug other than insulin * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure above or equal to 100 mmhg) * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
descriptive study on mri contrast of acute cerebral hemorrhage in different microangiopathies

Conditions: Cerebral Hemorrhage; Acute Lobar Haematoma

Summary: cerebral haemorrhage represents a minority of acute vascular syndromes (less frequent than ischemic stroke, at around 20%), but with a therapeutic impasse, having no specific treatment. arterial contrast ("spot sign") within the hematoma has been described in ct scans as a risk factor for further enlargement and poor prognosis. an equivalent marker has also been described in gadolinium-enhanced mri. by studying the radiological appearance of gadolinium "spot signs" on mri, which has better parenchymal resolution, the researchers propose to retrace the phenomenology of the acute phase of cerebral hemorrhage in order to better estimate the risk of radiological aggravation by subgroup, which could serve as a target population for future therapeutic trials.


Eligibility criteria:
inclusion criteria: * patients with acute cerebral hematomas from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy managed at nîmes university hospital; * patients who have undergone a follow-up cerebral ct scan in the event of worsening or for follow-up. exclusion criteria: * patient refusing to participate

Keywords: cerebral haemorrhage mri
the effect of erigeron injection on acute cerebral infarction serum vegf, mmp-9 and epc levels

Conditions: Cerebral Infarction

Summary: to study the effects of erigeron injection on human serum vegf, mmp-9 and epc levels after acute cerebral infarction,test is made by random double-blind controlled.patients with acute cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin group,and health people. the main indexes are the serum level of vegf, mmp-9 and epc.the review is made by the reference to nihss and so on. so, erigeron injection have the function of promoting angiogenesis in multiple targets through this test.

objective: to study the effects of erigeron injection on human serum vegf, mmp-9 and epc levels after acute cerebral infarction. method: 40 patients with acute cerebral infarction(in accordance with the inclusion criteria) were divided randomly into erigeron injection+aspirin group,aspirin group,and 20 health people. erigeron injection+aspirin group and aspirin group drew peripheral blood on the prior treatment,the posttreatment 1th, 3th and 7th day,and tested the level of vegf, mmp-9 and epc.tested the health people one time.

Eligibility criteria:
inclusion criteria: * patients aged no younger than 18yrs * attack within 72 hours * nihss score in the 2-25 points * ischemic stroke occurred for the first time, or with a history of stroke disease but without sequelae * signed the informed consents exclusion criteria: * patients aged younger than 18yrs * patients with tumor, coronary heart disease, valvular heart disease, psoriasis, rheumatism, hematologic diseases, infertility, varieties of acute inflammation * patients with severe cognitive impairment * refused to cooperate or been unable to cooperation for neurological disorders * cerebral hemorrhage or hemorrhagic cerebral infarction * unstable vital signs dued to massive cerebral infarction * patients with serious heart, liver and renal insufficiency

Keywords: promoting angiogenesis in multiple targets herbal medicine traditional chinese medicine random clinical trial